Prosthetic valve with protective sleeve around an outlet rim

ABSTRACT

An expandable prosthetic valve for implantation within a native heart valve may be provided. The prosthetic valve may include an expandable annular valve body. The valve body may include an atrial inlet opening and a ventricular outlet opening. The valve body may additionally include a plurality of tissue anchors extending from the valve body. The prosthetic valve may additionally include a flexible annular protective sleeve positioned about the rim of the valve body outlet opening and affixed to the outlet opening.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority from U.S. Provisional Patent Application No. 62/560,384, filed Sep. 19, 2017, which is hereby incorporated by reference in its entirety.

TECHNICAL FIELD

This disclosure relates generally to prosthetic valves and delivery systems for prosthetic valves. More specifically, this disclosure relates to prosthetic heart valves and methods thereof.

BACKGROUND

The native heart valves (the tricuspid valve, pulmonary valve, mitral valve, and aortic valve) play an important role in regulating flow of blood through the cardiovascular system. However, the native heart valves may become damaged or impaired due to, for example, cardiovascular diseases, infections, or congenital malformations, thus limiting the ability of the native heart valves to regulate blood flow. This deficiency may result in reduced cardiovascular function or even death.

To treat these conditions, prosthetic heart valves may be implanted at or near the site of a damaged or impaired native valve. A prosthetic heart valve may assist or replace the functionality of an impaired native valve, leading to better regulation of blood flow and improved cardiovascular function. However, many existing prosthetic heart valves require implantation via an open heart procedure, which is highly-invasive and may cause life-threatening complications. Other prosthetic valves may be collapsed within a prosthetic valve delivery system and advanced into the heart, at which point the prosthetic valve may be removed from the delivery system and expanded at the native valve site. However, many of these prosthetic valves are large in size and therefore difficult to deliver into the heart without causing damage to healthy tissue along the implantation route. In addition, once these prosthetic valves are situated within the heart, they may be difficult to securely implant at the native valve site due to their complex structure and the limited maneuverability of existing prosthetic valve delivery systems within the heart. Moreover, many prosthetic valves are so large that they may protrude several centimeters into surrounding heart chambers once they are implanted, impairing cardiac filling and causing injury to the anatomy within the heart.

Thus, there remains a need for prosthetic heart valves that are smaller in size but that are still configured to assist or replace the functionality of a diseased or damaged native heart valve. In addition, there remains a need for prosthetic heart valves that are more easily maneuvered into the heart and securely implanted at the site of a native heart valve. Moreover, there remains a need for improved prosthetic heart valve delivery systems that are configured to securely implant a prosthetic heart valve at an implantation site. The present disclosure provides prosthetic heart valves with a reduced axial length such that the prosthetic heart valves may be more easily delivered into the heart and may exhibit less protrusion into the chambers of the heart. The present disclosure also provides improved prosthetic heart valve delivery systems and methods of implanting prosthetic heart valves, such that prosthetic heart valves may be securely anchored at the implantation site.

SUMMARY

The present disclosure discloses prosthetic valves for implantation within a native valve and methods for implanting prosthetic valves within a native valve. Particular examples of the disclosure may pertain to a prosthetic valve formed at least partially of a valve body and a protective sleeve.

According to an exemplary embodiment of the present disclosure, an expandable prosthetic valve for implantation within a native heart valve is provided. The prosthetic valve includes an expandable annular valve body having an atrial inlet opening and a ventricular outlet opening. The valve body additionally includes a plurality of tissue anchors extending from the valve body. The prosthetic valve additionally includes a flexible annular protective sleeve positioned about the rim of the valve body outlet opening and affixed to the outlet opening.

The protective sleeve is constructed of a polymer. The polymer is PTFE. Stitching is passed around the protective sleeve to secure it relative to the rim of the valve body outlet opening. The stitching does not pass through the protective sleeve. The stitching passes between an area within the valve body and an area external to the valve body. The prosthetic sleeve wraps around the rim of the valve body outlet opening. The protective sleeve contacts a radially inner surface of the valve body and a radially outer surface of the valve body. The protective sleeve is configured to protect chordae tendineae from damage by the prosthetic valve. The protective sleeve is situated over a skirt layer extending about a circumference of the valve body. A thickness of the protective sleeve is larger than a thickness of the skirt layer. The protective sleeve does not contact the plurality of tissue anchors. The radial expansion and contraction of the valve body is substantially unimpeded by the protective sleeve. Movement of the plurality of tissue anchors between a radially-contracted configuration and a radially-expanded configuration is substantially unimpeded by the protective sleeve. The prosthetic valve additionally includes at least one post secured to the valve body and configured to engage a delivery tool. The at least one post extends in a ventricular direction beyond the protective sleeve. The at least one post is situated at a radially inward position relative to the protective sleeve. The prosthetic valve additionally includes a plurality of leaflets situated within the valve body. A point of connection between the leaflets and the valve body is aligned in a common lateral plane with the protective sleeve or situated in an atrial direction relative to the protective sleeve. The tissue anchors are configured to engage ventricular tissue of a native heart valve. The prosthetic valve additionally includes a plurality of atrial tissue anchors configured to engage atrial tissue of the native heart valve. The valve body includes an annular outer frame and an inner frame situated at least partially within the annular outer frame. The tissue anchors configured to engage ventricular tissue extend from the annular outer frame. The atrial tissue anchors extend from the inner frame. The protective sleeve contacts a radially inner surface of the inner frame and a radially outer surface of the annular outer frame.

Additional features and advantages of the disclosed embodiments will be set forth in part in the description that follows, and in part will be obvious from the description, or may be learned by practice of the disclosed embodiments. The features and advantages of the disclosed embodiments will be realized and attained by the elements and combinations particularly pointed out in the appended claims.

It is to be understood that both the foregoing general description and the following detailed description are examples and explanatory only and are not restrictive of the disclosed embodiments as claimed.

The accompanying drawings constitute a part of this specification. The drawings illustrate several embodiments of the present disclosure and, together with the description, serve to explain the principles of the disclosed embodiments as set forth in the accompanying claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a front elevation view of an exemplary frame for a prosthetic valve, consistent with various embodiments of the present disclosure.

FIG. 1B illustrates a perspective view of the exemplary frame of FIG. 1A, consistent with various embodiments of the present disclosure.

FIG. 2A illustrates a front elevation view of another exemplary frame for a prosthetic valve, consistent with various embodiments of the present disclosure.

FIG. 2B illustrates a top plan view of the exemplary frame of FIG. 2A, consistent with various embodiments of the present disclosure.

FIG. 2C illustrates an enlarged view of an atrial anchoring arm and a ventricular anchoring leg of the exemplary frame of FIG. 2A, consistent with various embodiments of the present disclosure.

FIG. 2D illustrates another front elevation view of the exemplary frame of FIG. 2A, consistent with various embodiments of the present disclosure.

FIG. 2E illustrates another top plan view of the exemplary frame of FIG. 2A, consistent with various embodiments of the present disclosure.

FIG. 3A illustrates a front elevation view of an inner frame of the exemplary frame of FIG. 2A, consistent with various embodiments of the present disclosure.

FIG. 3B illustrates an enlarged view of an atrial anchoring arm of the exemplary inner frame of FIG. 3A, consistent with various embodiments of the present disclosure.

FIG. 3C illustrates a front elevation view of an outer frame of the exemplary frame of FIG. 2A, consistent with various embodiments of the present disclosure.

FIG. 3D illustrates an enlarged view of a ventricular anchoring leg of the exemplary outer frame of FIG. 3C, consistent with various embodiments of the present disclosure.

FIG. 4A illustrates a cross-sectional view of the exemplary frame of FIG. 2A, consistent with various embodiments of the present disclosure.

FIG. 4B illustrates an enlarged view of a volume between an atrial anchoring arm and a ventricular anchoring leg of the exemplary frame of FIG. 4A, consistent with various embodiments of the present disclosure.

FIGS. 5A-5E illustrate structural changes in the exemplary frame of FIG. 2A during transitioning of the frame between a radially-contracted configuration and a radially-expanded configuration, consistent with various embodiments of the present disclosure.

FIG. 6A illustrates a front elevation view of an exemplary prosthetic valve, consistent with various embodiments of the present disclosure.

FIG. 6B illustrates a cross-sectional view of the exemplary prosthetic valve of FIG. 6A without leaflets, consistent with various embodiments of the present disclosure.

FIG. 6C illustrates a cross-sectional view of the exemplary prosthetic valve of FIG. 6A with leaflets, consistent with various embodiments of the present disclosure.

FIG. 6D illustrates a top plan view of the exemplary prosthetic valve of FIG. 6A with uninflated leaflets, consistent with various embodiments of the present disclosure.

FIG. 6E illustrates a top plan view of the exemplary prosthetic valve of FIG. 6A with inflated leaflets, consistent with various embodiments of the present disclosure.

FIG. 7A illustrates an exemplary prosthetic valve delivery system, consistent with various embodiments of the present disclosure.

FIG. 7B illustrates an enlarged view of a delivery capsule of the exemplary prosthetic valve delivery system of FIG. 7A, consistent with various embodiments of the present disclosure.

FIG. 7C illustrates an exemplary configuration of a telescoping catheter assembly and the delivery capsule of the exemplary prosthetic valve delivery system of FIG. 7A, consistent with various embodiments of the present disclosure.

FIG. 7D illustrates another exemplary configuration of the telescoping catheter assembly and delivery capsule of FIG. 7C, consistent with various embodiments of the present disclosure.

FIG. 8A illustrates another enlarged view of the exemplary delivery capsule of the prosthetic valve delivery system of FIG. 7A in a closed configuration, consistent with various embodiments of the present disclosure.

FIG. 8B illustrates the exemplary delivery capsule of FIG. 8A in an open configuration, consistent with various embodiments of the present disclosure.

FIG. 8C illustrates an interior view of the exemplary delivery capsule of FIG. 8A in the closed configuration, consistent with various embodiments of the present disclosure.

FIG. 9 illustrates advancement of the exemplary prosthetic valve delivery system of FIG. 7A into the left atrium, consistent with various embodiments of the present disclosure.

FIGS. 10A-10H depict implantation of the prosthetic valve of FIGS. 6A-6E within a native mitral valve by the exemplary prosthetic valve delivery system of FIG. 7A, consistent with various embodiments of the present disclosure.

DETAILED DESCRIPTION

Exemplary embodiments are described with reference to the accompanying drawings. In the figures, which are not necessarily drawn to scale, the left-most digit(s) of a reference number identifies the figure in which the reference number first appears. Wherever convenient, the same reference numbers are used throughout the drawings to refer to the same or like parts. While examples and features of disclosed principles are described herein, modifications, adaptations, and other implementations are possible without departing from the spirit and scope of the disclosed embodiments. Also, the words “comprising,” “having,” “containing,” and “including,” and other similar forms are intended to be equivalent in meaning and be open ended in that an item or items following any one of these words is not meant to be an exhaustive listing of such item or items, or meant to be limited to only the listed item or items. It should also be noted that as used in the present disclosure and in the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.

In some embodiments of the present disclosure, an “atrial direction” may refer to a direction extending towards an atrium of the heart. For example, from a location within the left ventricle or the mitral valve, an atrial direction may refer to a direction extending towards the left atrium. Additionally, from a location within an atrium (e.g., the left atrium), an atrial direction may refer to a direction extending away from an adjacent atrioventricular valve (e.g., the mitral valve) and further into the atrium. For example, in FIGS. 10G and 10H, an atrial direction may refer to a direction extending upwards from prosthetic valve 6000 towards atrium 9010. In some exemplary embodiments, an atrial direction need not necessarily be parallel to a longitudinal axis of a prosthetic valve (e.g., longitudinal axis 2800 illustrated in FIG. 2A), so long as the direction is angled towards an atrium. The atrial direction may be parallel to a longitudinal axis of a prosthetic valve in some cases. In some embodiments, a “non-ventricular direction” may refer to a direction that does not extend towards a ventricle of the heart. A “non-ventricular direction” may extend in an atrial direction, or it may extend laterally in a direction perpendicular to a ventricular direction.

In some exemplary embodiments of the present disclosure, a “ventricular direction” may refer to a direction extending towards a ventricle of the heart. From a location within the left atrium or the mitral valve, a ventricular direction may refer to a direction extending towards the left ventricle. Additionally, from a location within a ventricle (e.g., the left ventricle), a ventricular direction may refer to a direction extending away from an adjacent atrioventricular valve (e.g., the mitral valve) and further into the ventricle. For example, in FIGS. 10G and 10H, a ventricular direction may refer to a direction extending downwards from prosthetic valve 6000 towards ventricle 9020. In some exemplary embodiments, a ventricular direction need not necessarily be parallel to a longitudinal axis of a prosthetic valve (e.g., longitudinal axis 2800 illustrated in FIG. 2A), so long as the direction is angled towards a ventricle. The ventricular direction may be parallel to a longitudinal axis of a prosthetic valve in some cases. In some embodiments, a “non-atrial direction” may refer to a direction that does not extend towards an atrium of the heart. A non-atrial direction may extend in a ventricular direction, or it may extend laterally in a direction perpendicular to an atrial direction.

Exemplary embodiments generally relate to prosthetic valves for implantation within a native valve and methods for implanting prosthetic valves within a native valve. In addition, exemplary embodiments generally relate to systems and methods for implantation of prosthetic valves by prosthetic valve delivery systems. While the present disclosure provides examples relating to prosthetic heart valves, and in particular prosthetic mitral valves, as well as delivery systems for prosthetic heart valves, it should be noted that aspects of the disclosure in their broadest sense are not limited to a prosthetic heart valve. Rather, the foregoing principles may be applied to other prosthetic valves as well. In various embodiments in accordance with the present disclosure, the term prosthetic valve refers generally to an implantable valve configured to restore and/or replace the functionality of a native valve, such as a diseased or otherwise impaired native heart valve.

An exemplary prosthetic valve may include a prosthetic valve configured to render a native valve structure non-functional, and may thus replace the function of the native valve. For example, an exemplary prosthetic valve may have a size and shape similar to the valve being replaced and may include a number of leaflet-like structures to regulate fluid flow and prevent backflow of blood through the valve. Additionally, or alternatively, an exemplary prosthetic valve may also include a prosthetic valve configured to leave the native valve structure intact and functional. An exemplary prosthetic valve may include a mitral valve, tricuspid valve, aortic valve, or pulmonary valve, as well as a valve outside of the heart, such as a venous valve, lymph node valve, ileocecal valve, or any other structure configured to control and/or regulate fluid flow in the body. An exemplary prosthetic valve may additionally or alternatively be configured to replace a failed bioprosthesis, such as a failed heart valve prosthesis.

FIG. 1A illustrates a front elevation view of an exemplary frame 1000 for a prosthetic valve. FIG. 1B illustrates a perspective view of frame 1000. Frame 1000 may be constructed of a shape memory material such as nickel titanium alloy (Nitinol) and may be configured to support other components of the prosthetic valve, such as prosthetic leaflets and protective cover layers. Frame 1000 may include an annular outer frame 1200 and an inner frame 1400 situated at least partially within the outer frame 1200. Annular outer frame 1200 and inner frame 1400 may be secured together by pins, screws, welding, soldering, adhesive, magnets, and/or any other suitable mechanism. For example, FIGS. 1A and 1B depict annular outer frame 1200 and inner frame 1400 connected by a plurality of connector pins 1040.

Annular outer frame 1200 may include an outer frame tubular portion 1220, which may be formed of a plurality of struts intersecting at junctions to form a wire mesh, stent-like, or cage-like structure of the outer frame tubular portion 1220. Annular outer frame 1200 may also include at least one ventricular anchoring leg 1240, which may be configured to extend radially outward from the outer frame tubular portion and which may contact, or otherwise engage, tissue within or near the native valve to anchor the prosthetic valve within the native valve. In some embodiments, exemplary valve frame 1000 may include twelve ventricular anchoring legs 1240, which may be configured to engage ventricular tissue of a native atrioventricular valve.

Inner frame 1400 may include an inner frame tubular portion 1420, which may be formed of a plurality of struts intersecting at junctions to form a wire mesh, stent-like, or cage-like structure of the inner frame tubular portion 1420. Inner frame 1400 may also include at least one atrial anchoring arm 1440, which may be configured to extend radially outward from the inner frame tubular portion and which may contact, or otherwise engage, tissue within or near the native valve to anchor the prosthetic valve within the native valve. In some embodiments, exemplary valve frame 1000 may include twelve atrial anchoring arms 1440, which may be configured to engage atrial tissue of a native atrioventricular valve.

Outer frame tubular portion 1220 and inner frame tubular portion 1420 may together form an annular valve body 1020 of the prosthetic valve, which may have at least one opening and from which the ventricular anchoring legs 1240 and atrial anchoring arms 1440 may extend. Annular valve body 1020 may include an axial lumen 1022 extending through the annular valve body 1020 along a longitudinal axis 1800 of the prosthetic valve. In some embodiments, annular valve body 1020 may be configured to receive a flow control device, such as one or more prosthetic leaflets, within axial lumen 1022. Optionally, annular valve body 1020 may include one or more atrial end delivery posts 1027 along an atrial end (i.e., top end) of the annular valve body and/or one or more ventricular end delivery posts 1028 along a ventricular end (i.e., bottom end) of the annular valve body. Delivery posts 1027 and 1028 may be configured to removably engage a delivery device of the prosthetic valve, for example, to assist with placement of frame 1000 within or near a native valve.

FIG. 2A illustrates a front view of another exemplary frame 2000 for a prosthetic valve. FIG. 2B illustrates a top plan view of the frame 2000. Frame 2000 may include an annular outer frame 2200 and an inner frame 2400 situated at least partially within the annular outer frame 2200. Annular outer frame 2200 and inner frame 2400 may be secured together by pins, screws, welding, soldering, adhesive, magnets, and/or any other suitable mechanism. For example, FIGS. 2A and 2B depict annular outer frame 2200 and inner frame 2400 connected by a plurality of connector pins 2040.

Annular outer frame 2200 may include an outer frame tubular portion 3605, which may be formed of a plurality of struts intersecting at junctions to form a wire mesh, stent-like, or cage-like structure of the outer frame tubular portion 3605. For example, as illustrated in FIG. 2A, annular outer frame 2200 may include outer frame atrial circumferential struts 3608 a, outer frame leg base struts 3608 b, and outer frame ventricular circumferential struts 3608 c intersecting at atrial end outer frame junctions 3602, leg attachment junctions 3802, outer frame junctions 3804, and ventricular end outer frame junctions 3604 to form outer frame tubular portion 3605. Annular outer frame 2200 may also include at least one ventricular anchoring leg 2240, which may extend from leg attachment junction 3802 of the outer frame tubular portion 3605 and which may be configured to engage ventricular tissue of a native valve to anchor the prosthetic valve in the native valve. The at least one ventricular anchoring leg 2240 may include a proximal leg end 3622, which may be the end of the leg connected to the outer frame tubular portion, and a distal leg end 2244, which may be situated radially outward from the outer frame tubular portion. As shown in FIG. 2B, the at least one ventricular anchoring leg 2240 may include at least one opening 2242.

Inner frame 2400 may include an inner frame tubular portion 3005, which may be formed of a plurality of struts intersecting at junctions to form a wire mesh, stent-like, or cage-like structure of the inner frame tubular portion 3005. For example, as illustrated in FIG. 2A, inner frame 2400 may include inner frame atrial struts 3008 a, inner frame intermediate struts 3008 b, and inner frame ventricular struts 3008 c intersecting at atrial end inner frame junctions 3002, arm attachment junctions 3202, inner frame strut junctions 3204, and ventricular end inner frame junctions 3004 to form inner frame tubular portion 3005. Inner frame 2400 may also include at least one atrial anchoring arm 2440, which may extend from arm attachment junction 3202 of the inner frame tubular portion 3005 and which may be configured to engage atrial tissue of a native valve to anchor the prosthetic valve in the native valve. The at least one atrial anchoring arm 2440 may include a proximal arm end 3020, which may be the end of the arm connected to the inner frame tubular portion, and a distal arm end 2444, which may be situated radially outward from the inner frame tubular portion. As shown in FIG. 2, the at least one atrial anchoring arm 2440 may include a proximal arm opening 2441 and a distal arm opening 2442.

Outer frame tubular portion 3605 and inner frame tubular portion 3005 may together form an annular valve body 2020 of the prosthetic valve, which may have at least one opening and from which the ventricular anchoring leas 2240 and atrial anchoring arms 2440 may extend. Annular valve body 2020 may include an axial lumen 2022 extending through the annular valve body 2020 along a longitudinal axis 2800 of the prosthetic valve. Annular valve body 2020 may have an atrial end 2024, a ventricular end 2025 opposite the atrial end, and an intermediate portion 2026 extending between the atrial and ventricular ends. In some embodiments, the atrial end may refer to the portion of the annular valve body configured to be situated at a location within the atrium that is furthest from an adjacent ventricle, when the prosthetic valve is implanted in a native valve. Similarly, the ventricular end may refer to the portion of the annular valve body configured to be situated at a location within the ventricle that is furthest from an adjacent atrium, when the prosthetic valve is implanted in a native valve. The intermediate portion 2026 may extend between the atrial end 2024 and ventricular end 2025. In some embodiments, annular valve body 2020 may include one or more ventricular end delivery posts 1028 along the ventricular end 2025 of the annular valve body. Axial lumen 2022 may include an inlet opening 2032 at the atrial end of the annular valve body, as well as an outlet opening 2036 at the ventricular end of the annular valve body.

FIG. 2C illustrates an enlarged view of an atrial anchoring arm 2440 and a ventricular anchoring leg 2240 of frame 2000. Ventricular anchoring leg 2240 may include an inner, atrially-facing leg surface 2248 and an outer, ventricularly-facing leg surface 2249. Atrial anchoring arm 2440 may include an atrially-facing arm surface 2448 and a ventricularly-facing arm surface 2449. In some embodiments, atrial anchoring arm 2440 may include an arm portion 2446 configured to be arranged in a common lateral plane with leg portion 2246 of the ventricular anchoring leg 2240. That is, leg portion 2246 and arm portion 2446 may be positioned at the same axial position along longitudinal axis 2800.

FIG. 2D illustrates another front elevation view of frame 2000. The exemplary prosthetic valve, as well as frame 2000, may have an axial height 2560, which may extend between terminal arm ends 2444 and ventricular end 2025 of the annular valve body. Inner frame tubular portion 3005 may have an axial height 2530, which ay extend between atrial end inner frame junctions 3002 and ventricular end inner frame junctions 3004. Annular outer frame 2200 may have an axial height 2550, which may extend between terminal leg ends 2244 and ventricular end 2025 of the annular valve body. Outer frame tubular portion 3605 may have an axial height 2570, which may extend between atrial end cuter frame junctions 3602 and ventricular end outer frame junctions 3604. In some embodiments, frame 2000 may have a ventricular device protrusion distance 2540, which may represent the distance over which the prosthetic valve protrudes into a left ventricle when the prosthetic valve is implanted in a native mitral valve. Annular valve body 2020 may include a valve inlet radius 2520, which may be the radius of atrial inlet opening 2032.

FIG. 2E illustrates another top plan view of frame 2000. The atrial anchoring arms 2440 may have a length 2580, and the ventricular anchoring legs 2240 may have a length 2590. The terminal arm ends 2444 may define an atrial anchoring arm circumference 2640. The terminal leg ends 2244 may define a ventricular anchoring leg circumference 2620, which may be concentric with atrial anchoring arm circumference 2640. Inflexible portions 3402 of the atrial anchoring arms (illustrated in FIG. 3B) may have a length 2581. Serpentine structures 3406 of the atrial anchoring arms (illustrated in FIG. 3B) may have a length 2582.

FIG. 3A illustrates a front elevation view of inner frame 2400. The atrial end inner frame junctions 3002 and ventricular end inner frame junctions 3004 may form the atrial end and ventricular end, respectively, of inner frame 2400. Inner frame intermediate portion 3006 may extend between atrial end inner frame junctions 3002 and ventricular end inner frame junctions 3004. Inner frame tubular portion 3005 may have a radially inner surface 3018 and a radially outer surface 3016. Inner frame atrial struts 3008 a and inner frame intermediate struts 3008 b may intersect at atrial end inner frame junctions 3002, arm attachment junctions 3202, arid strut junctions 3204 to form a first, atrial row of closed cells 3012. Inner frame intermediate struts 3008 b and inner frame ventricular struts 3008 c may intersect at arm attachment junctions 3202, strut junctions 3204, and ventricular end inner frame junctions 3004 to form a second, ventricular row of closed cells 3014. At least one inner frame atrial strut 3008 a may have a cross-sectional area 3010. At least one atrial anchoring arm 2440 may have a cross-sectional area 3022.

FIG. 3B illustrates an enlarged view of an atrial anchoring arm 2440 of inner frame 2400. Atrial anchoring arm 2440 may include a proximal arm portion 3502 configured to extend in an atrial direction, intermediate arm portion 3504 configured to extend in a ventricular direction, and distal arm portion 3506 configured to extend in an atrial direction. Arm transition portion 3508 may represent the transition between intermediate arm portion 3504 and distal arm portion 3506. Atrial anchoring arm 2440 may also include an inflexible portion 3402 extending to proximal arm end 3020, as well as a serpentine structure 3406, which may be situated radially external to the inflexible portion 3402. Inflexible portion 3402 may have a proximal end 3402 p, a distal end 3402 d, and a cross-sectional area 3402 c. Serpentine structure 3406 may have a cross-sectional area 3406 c. In some embodiments, atrial anchoring arm 2440 may include a terminal arm region 3408 situated radially external to serpentine structure 3406. Distal arm opening 2442 may be situated within terminal arm region 3408.

FIG. 3C illustrates a front elevation view of outer frame 2200. The atrial end outer frame junctions 3602 and ventricular end outer frame junctions 3604 may form the atrial end and ventricular end, respectively, of annular outer frame 2200. Outer frame intermediate portion 3606 may extend between atrial end outer frame junctions 3602 and ventricular end outer frame junctions 3604. Outer frame tubular portion 3605 may have a radially outer surface 3618 and a radially inner surface 3620. The outer frame atrial circumferential struts 3608 a, outer frame leg base struts 3608 b, and outer frame ventricular circumferential struts 3608 c may intersect at the atrial end outer frame junctions 3602, leg attachment junctions 3802, outer frame junctions 3804, and ventricular end outer frame junctions 3604 to form closed cells 3616. At least one outer frame atrial circumferential strut 3608 a may have a cross-sectional area 3610 and a width 3612. At least one outer frame leg base strut 3608 b may have a cross-sectional area 3614. At least one ventricular anchoring leg may have a cross-sectional area 3624 and a radially outer surface width 3626.

FIG. 3D illustrates an enlarged view of a portion of a ventricular anchoring leg 2240 of annular outer frame 2200. Ventricular anchoring leg 2240 may include a first, proximal curved portion 3807 and a second, distal curved portion 3808. In some embodiments, proximal curved portion 3807 may face radially outward. Additionally, or alternatively, distal curved portion 3808 may face radially inwards.

FIG. 4A illustrates a cross-sectional view of frame 2000, and FIG. 4B illustrates an enlarged view of a portion of FIG. 4A depicting a volume 4000 formed between the atrial anchoring arms 2440 and ventricular anchoring legs 2240. FIG. 4B also depicts an outer surface 4010 and inner surface 4020 of annular valve body 2020. In some embodiments, volume 4000 may be bounded by the ventricularly-facing surfaces 2449 of atrial anchoring arms 2440, by the inner, atrially-facing surfaces 2248 of ventricular anchoring legs 2240, and by the outer surface 4010 of the annular valve body 2020.

FIG. 5A illustrates a configuration of the exemplary prosthetic valve in which annular valve body 2020, atrial anchoring arms 2440, and ventricular anchoring legs 2240 are arranged in a radially-contracted configuration. In some embodiments, the configuration illustrated in FIG. 5A may constitute a radially-contracted configuration of the prosthetic valve,

FIG. 5B illustrates a configuration of the exemplary prosthetic valve in which annular valve body 2020 and atrial anchoring arms 2440 are arranged in a radially-contracted configuration. In the configuration of FIG. 5B, the ventricular anchoring legs 2240 may deflect radially outward away from annular valve body 2020, into a radially-expanded configuration of the ventricular anchoring legs 2240.

FIG. 5C illustrates a configuration of the exemplary prosthetic valve in which annular valve body 2020 and ventricular anchoring legs 2240 are arranged in a radially-contracted configuration. In the configuration of FIG. 50, the atrial anchoring arms 2440 may deflect radially outward away from annular valve body 2020, into a radially-expanded configuration of the atrial anchoring arms 2440.

FIG. 5D illustrates a configuration of the exemplary prosthetic valve in which the atrial anchoring arms 2440 and ventricular anchoring legs 2240 may deflect radially outward away from annular valve body 2020 into their respective radially-expanded configurations, while annular valve body 2020 remains in a radially-contracted configuration. In the configuration of FIG. 5D, an axial distance 5004 may be formed between the atrial anchoring arms 2440 and the terminal ends 2244 of the ventricular anchoring legs 2240.

FIG. 5E illustrates a configuration of the exemplary prosthetic valve in which annular valve body 2020, atrial anchoring arms 2440, and ventricular anchoring legs 2240 are arranged in a radially-expanded configuration. In some embodiments, the configuration illustrated in FIG. 5E may constitute a radially-expanded configuration of the prosthetic valve.

FIG. 6A illustrates a front elevation view of prosthetic valve 6000. In some embodiments, prosthetic valve 6000 may be assembled upon frame 2000. Prosthetic valve 6000 may be configured for implantation within or near a native valve structure and may be configured to restore and/or replace the functionality of a native valve, such as a diseased or otherwise impaired native valve. Prosthetic valve 6000 may include valve frame 2000, including annular valve body 2020, the atrial anchoring arms 2440, and the ventricular anchoring legs 2240. Prosthetic valve 6000 may also include a skirt layer 6100 configured around an external surface of a portion of the annular valve body. Prosthetic valve 6000 may additionally include a first cuff sheet 6210, which may be connected to skirt layer 6100 via stitching 6104, as well as a second cuff sheet 6220, which may be connected to first cuff sheet 6210 via stitching 6420. In some embodiments, the first cuff sheet 6210 and second cuff sheet 6220 by extend around the terminal ends 2444 of the atrial anchoring arms 2440. Skirt layer 6100, first cuff sheet 6210, and second cuff sheet 6220 may be constructed of fluid-impermeable material and may accordingly be configured to prevent passage of blood or other fluids through portions of the prosthetic valve 6000 outside of the axial lumen 2022.

In some embodiments, prosthetic valve 6000 may additionally include a protective sleeve 6102 wrapped around the rim 6800 of the ventricular outlet opening of annular valve body 2020; protective sleeve 6102 may be secured to annular valve body 2020 by stitching 6108. Additionally, or alternatively, prosthetic valve 6000 may include at least one liner 6310 extending around an external surface of the ventricular anchoring legs 2240, with at least one protective layer 6330 positioned around the distal leg ends 2244 and at least one protective covering 6320 wrapped around the proximal leg ends 3622. In some embodiments, the at least one protective covering 6320 may be secured to the skirt layer 6100 via stitching 6322.

FIG. 6B illustrates a cross-sectional view of prosthetic valve 6000, without prosthetic leaflets situated within the axial lumen 2022. As illustrated in FIG. 6B, prosthetic valve 6000 may additionally include a liner 6400 covering at least a portion of the inner surface 4020 of the annular valve body 2020. Liner 6400 may be secured to the annular valve body 2020 via stitching 6430 and to the second cuff sheet 6220 via stitching 6410. First cuff sheet 6210, second cuff sheet 6220, and inner liner 6400 may together form an inflatable cuff 6200 having an interior volume 6500. In some embodiments, inflatable cuff 6200 may be secured to atrial anchoring arm 2440 via connector 6440. Blood may enter the cuff 6200 through openings 6230, causing the cuff 6200 to inflate radially outwards and axially in an atrial direction. In some embodiments, cuff 6200 may inflate radially outwards and press against tissue of the native valve. This engagement between the cuff and tissue of the native valve may form a barrier to flow of blood and other fluids around the outer circumference of the prosthetic valve 6000.

FIG. 60 illustrates a cross-sectional view of prosthetic valve 6000 with prosthetic leaflets 6602 and 6604 situated within the axial lumen 2022. In some embodiments, prosthetic valve 6000 may also include a third prosthetic leaflet 6606, which may not be visible in the view of FIG. 60. The leaflets 6602, 6604, and 6606 may be secured to inner liner 6400 via stitching 6608 and may include a connector 6610 wrapping around the ventricular end delivery posts 2028 to secure the leaflets 6602, 6604, and 6606 to the valve frame 2000.

FIG. 6D illustrates a top plan view of prosthetic valve 6000, with leaflets 6602, 6604, and 6606 arranged in an open, uninflated configuration. In the open configuration, a space may be formed in the middle of the leaflets, permitting fluid to pass through the axial lumen 2022 of the prosthetic valve 6000. FIG. GE illustrates a top plan view of prosthetic valve 6000, with leaflets 6602, 6604, and 6606 arranged in a closed, coapted configuration. In the closed configuration, the leaflets may press together such that the opening between them is closed. For example, the point of contact 6007 between two adjacent leaflets may extend to the center of the axial lumen; as a result, the leaflets may block fluid passage through the axial lumen 2022 of the prosthetic valve 6000.

FIG. 7A illustrates a prosthetic valve delivery system 7000. Delivery system 7000 may be configured to deliver an implant prosthetic valve 6000 within a native valve, such as a native mitral valve. Prosthetic valve delivery system 7000 may include a control handle assembly 7100, a telescoping catheter assembly 7200, a delivery capsule 7300 configured to retain a prosthetic valve (e.g. valve 6000), and, optionally, a stand 7400.

Control handle assembly 7100 may include an outer sheath control handle 7120 having a steering knob 7122 configured to steer an outer sheath 7210 of the telescoping catheter assembly 7200. Control handle assembly 7100 may also include a guide catheter control handle 7140 having a steering knob 7142 configured to steer a guide catheter 7220 of the telescoping catheter assembly 7200.

Control handle assembly 7100 may also include an implant catheter control handle 160 having a steering knob 7168 configured to steer an implant catheter 8100 of the telescoping catheter assembly 7200. Implant catheter control handle 7160 may also include a proximal capsule portion slider 7162, a distal capsule portion knob 7170, and a distal capsule portion knob lock 7172 configured to control release of the prosthetic valve 6000 from within delivery capsule 7300. Implant catheter control handle 7160 may also include a slide lock 7166 configured to lock the implant catheter control handle 7160 at a position within track 7420 of stand 7400.

Control handle assembly 7100 may also include a cradle 7180, which may be secured to stand 7400 via a locking mechanism that can be released by actuated of release button 7184. Cradle 7180 may include a rotation knob 7182 configured to control rotation of the outer sheath 7210 and guide catheter 7220. Cradle 7180 may also include a rotation knob 7186 configured to control rotation of the implant catheter 8100. Cradle 7180 may also include a knob 7188 configured to control relative axial movement between outer sheath control handle 7120 (which may be secured to outer sheath 7210) and guide catheter control handle 7140 (which may be secured to guide catheter 7220).

FIG. 7B illustrates an enlarged view of delivery capsule 7300 of prosthetic valve delivery system 7000. Delivery capsule 7300 may include a proximal capsule portion 7320 and a distal capsule portion 7340 with a nose cone 7360 secured to the distal capsule portion 7340. A nose cone distal tip 7365 may form the distal end of the delivery capsule 7300. The telescoping catheter assembly 7200 may include a capsule shaft 7230 secured to, and configured to control movement of, the proximal capsule portion 7320 (e.g., due to connection 8400 between the capsule shaft 7230 and proximal capsule portion 7320, as illustrated in FIG. 80). Implant catheter 8100 may extend within proximal capsule portion 7320 and may have a valve anchor disc 8200 connected to the distal end of the implant catheter 8100. A torque shaft 8300 may extend from the implant catheter 8100 and may be connected to distal capsule portion 7340; accordingly, torque shaft 8300 may be configured to control axial movement of the distal capsule portion 7340 relative to the implant catheter 8100 and valve anchor disc 8200. The proximal capsule portion 7320 and a distal capsule portion 7340 may be configured to retain prosthetic valve 6000, with the prosthetic valve 6000 secured against axial movement by valve anchor disc 8200. Control handle assembly 7100 may be configured to control movement of the proximal capsule portion 7320 and a distal capsule portion 7340, and thus may also control release of the prosthetic valve 6000 from within the delivery capsule 7300.

FIGS. 70 and 7D illustrate exemplary configurations of the telescoping catheter assembly 7200. Outer sheath 7210 and guide catheter 7220 may include respective bending portions 7215 and 7225, at which the outer sheath 7210 and guide catheter 7220 may be configured to bend within their respective steering planes 7212 and 7222. In some embodiments, bending of the outer sheath 7210 within the first steering plane 7212 may be controlled by the outer sheath steering knob 7122 of the control handle assembly 7100. Additionally, or alternatively, bending of the guide catheter 7220 within the second steering plane 7222 may be controlled by the guide catheter steering knob 7142 of the control handle assembly 7100. In some embodiments, under control of the control handle assembly 7100, the outer sheath 7210, guide catheter 7220, and implant catheter 8100 may be steered so as to correctly position the delivery capsule 7300 within a native valve for implantation of the prosthetic valve.

FIG. 8A illustrates an enlarged view of delivery capsule 7300 in a closed configuration, while FIG. 8B illustrates an enlarged view of delivery capsule 7300 in an open configuration. In the closed configuration of FIG. 8A, the distal capsule portion 7340 and proximal capsule portion 7320 may be brought together to form an enclosed compartment in which prosthetic valve 6000 may be retained. In the open configuration of FIG. 8B, the distal capsule portion 7340 and proximal capsule portion 7320 may be drawn apart. In some embodiments, the delivery capsule 7300 may be configured such that the distal capsule portion 7340 and proximal capsule portion 7320 are moved apart from each other, the prosthetic valve 6000 may be sequentially deployed from within the delivery capsule and implanted within a native valve.

FIG. 80 illustrates an interior view of delivery capsule 7300 with prosthetic valve 6000 retained within the delivery capsule. Although only the valve frame 2000 of the prosthetic valve 6000 is illustrated in FIG. 8C, one of ordinary skill will understand that the entire prosthetic valve 6000 depicted in FIGS. 6A-6E may be retained within delivery capsule 7300 in the configuration illustrated in FIG. 8C.

In the embodiment illustrated in FIG. 80, at least a portion of the annular valve body 2020 and ventricular anchoring legs 2240 of the prosthetic valve 6000 may be retained within the distal capsule portion. Additionally, or alternatively, at least a portion of atrial anchoring arms 2440 may be retained within proximal capsule portion 7320. In some embodiments, valve anchor disc 8200 may include a number of recesses 8205 configured to receive and retain the ventricular end delivery posts 2028 of the prosthetic valve 6000. For example, the valve anchor disc 8200 may include at least the same number of recesses 8205 as there are delivery posts 2028 of the prosthetic valve 6000. In some embodiments, the delivery posts 2028 may be retained within the recesses 8205 so long as the annular valve body 2020 remains in a radially-contracted configuration; the engagement between the valve anchor disc 8200 and delivery posts 2028 may secure the prosthetic valve 6000 against axial movement. Upon radial expansion of the annular valve body 2020, the delivery posts 2028 may slide or expand out of the recesses 8205, freeing the prosthetic valve 6000 from engagement with the valve anchor disc 8200.

FIG. 9 illustrates one exemplary advancement route of the delivery capsule 7300 to the left atrium. In the example illustrated in FIG. 9, the delivery capsule 7300 may be steered through the vena cava into the right atrium 9210 and may pierce the interatrial septum and enter the left atrium 9010. Alternatively, the delivery capsule may be delivered to the heart by other routes. FIG. 9 also depicts the left ventricle 9020, the mitral valve 9030, the chordae tendineae 9022, the aortic valve 9045, and the aorta 9040.

FIGS. 10A-10H depict an exemplary implantation method of prosthetic valve 6000 within a mitral valve 9030. In FIG. 10A, the delivery capsule 7300 may be coaxially aligned with the mitral valve 9030. In some embodiments, the prosthetic valve 6000 may be held within the delivery capsule 7300 while the prosthetic valve is arranged in the configuration of FIG. 5A. In FIG. 10B, the delivery capsule 7300 may be distally advanced into the mitral valve 9030. In FIG. 10C, the distal capsule portion 7340 may be distally advanced relative to the rest of the delivery capsule 7300. This may release the ventricular anchoring legs 2240 from the distal capsule portion 7340, e the atrial anchoring arms 2440 and annular valve body 2020 remain constrained within the delivery capsule. In the example shown in FIG. 100, the ventricular anchoring legs 2240 may be released from the delivery capsule 7300 within the atrium 9010. In some embodiments, the prosthetic valve 6000 may assume the configuration of FIG. 5B when the ventricular anchoring legs 2240 are released in the step depicted in FIG. 100.

In FIG. 10D, the released ventricular anchoring legs 2240 may be passed through the mitral valve 9030 and into the left ventricle 9020. In FIG. 10E, the released legs 2240 may be proximally retracted until the ventricular anchoring legs come into contact with the ventricular tissue of the mitral valve 9030. In FIG. 10F, the proximal capsule portion 7320 may be retracted proximally, thus releasing the atrial anchoring arms 2440 within atrium 9010 while the annular valve body 2020 remains radially constrained within the distal capsule portion 7340. In some embodiments, the prosthetic valve 6000 may assume the configuration of FIG. 5D when the atrial anchoring arms 2440 are released in the step of FIG. 10F.

In FIG. 10G, the distal capsule portion 7340 may be advanced further until the annular valve body 2020 is released from the capsule and allowed to radially expand. Radial expansion of the annular valve body 2020 may allow the prosthetic valve to assume the fully-expanded configuration illustrated in FIG. 5E. At this stage, prosthetic valve 6000 may be securely implanted within mitral valve 9030. In FIG. 10H, the delivery system 7000, including capsule 7300, may be removed.

Various embodiments of the present disclosure relate to prosthetic valves, including prosthetic heart valves. While the present disclosure provides examples of prosthetic heart valves, and in particular prosthetic mitral valves, it should be noted that aspects of the disclosure in their broadest sense are not limited to a prosthetic mitral valve. Rather, the foregoing principles may be applied to other prosthetic valves as well. Prosthetic heart valve 6000, illustrated in FIGS. 6A-6E, is one example of a prosthetic valve in accordance with the present disclosure.

In some embodiments, an exemplary prosthetic valve may be configured for implantation within a native atrioventricular valve and may regulate blood flow between the atrium and ventricle. For example, prosthetic heart valve 6000 illustrated in FIGS. 6A-6C may include a fluid-impervious cuff 6200 configured to extend from an inner lumen 2022 of the prosthetic valve to terminal arm ends 2444 of a plurality of atrial anchoring arms 2440. Because cuff 6200 is constructed of a fluid-impervious material, cuff 6200 may be configured to minimize or block flow of blood and other fluids through any portion of the prosthetic valve 6000 except for lumen 2022. In addition, atrial anchoring arms 2440 of the prosthetic valve (including terminal arm ends 2444) may be configured to contact and, in some embodiments, press against atrial tissue of a native heart valve. This is illustrated in FIGS. 10G-10H, which depict atrial anchoring arms 2440 of prosthetic valve 6000 arranged in contact with, and exerting a ventricularly-directed force (that is, a force directed downwards toward ventricle 9020) upon atrial tissue of native mitral valve 9030. As a result, cuff 6200 of prosthetic valve 6000 may also be configured to minimize or block passage of blood and other fluids between the prosthetic valve 6000 (including terminal arm ends 2444) and native valve tissue, a condition known as perivalvular leakage. As a result, prosthetic valve 6000 may be configured to prohibit passage of blood and other fluids between atrium 9010 and ventricle 9020, except by passage through inner lumen 2022, in which leaflets 6602, 6604, and 6606 may be situated.

In some embodiments, an exemplary prosthetic valve may be expandable, such as between a radially-contracted configuration (e.g., a crimped state) and a radially-expanded configuration. In some embodiments, the exemplary prosthetic valve may be configured to be radially contracted into a radially-contracted configuration for introduction to the implantation site, such as on or within a delivery device. Accordingly, in some embodiments, the radially-contracted configuration may also be a delivery configuration, in which the prosthetic valve is arranged for delivery to the implantation site Once at or near the implantation site, the prosthetic valve may be radially expanded to a radially-expanded configuration, in which the prosthetic valve may be anchored at the implantation site. Accordingly, in some embodiments, the radially-expanded configuration may also be a deployed configuration, in which the prosthetic valve is released from the delivery tool and seated at the implantation site.

In some embodiments, an exemplary prosthetic valve may be configured for self-expansion to the radially-expanded configuration; that is, the prosthetic valve may be biased to assume the radially-expanded configuration due to, at least in part, the design and/or material composition of the prosthetic valve. The self-expanding prosthetic valve may be constructed of a shape memory material such as nickel titanium alloy (Nitinol), which may permit the prosthetic valve to expand to a pre-determined diameter upon removal of a constraining force and/or application of heat or energy. For example, the prosthetic valve may be contracted and held in the radially-contracted configuration by a constraining device, such as a sheath, catheter, stent, or delivery capsule. An example of such a constraining device is illustrated in FIGS. 8A-8C, which illustrates prosthetic heart valve 6000 held in a radially-contracted configuration within delivery capsule 7300. When the prosthetic valve is positioned at or near the implantation site, the constraining force may be removed and the prosthetic valve allowed to self-expand to the radially-expanded configuration. Additionally, or alternatively, an exemplary prosthetic valve may be configured to expand due to application of radially expansive forces thereupon. For example, the prosthetic valve may be placed, in its radially-contracted configuration, upon an expansion device such as a balloon catheter. Upon positioning at the implantation site, the expansion device may exert an outwardly-directed force upon the prosthetic valve, causing it to expand to the fully-expanded configuration.

In some embodiments, a prosthetic valve may be configured for implantation at a treatment site within the body, such as within or adjacent to a native heart valve structure. In some embodiments, a prosthetic valve may be configured for transcatheter delivery to the implantation site via a variety of approaches, such as transapically, transatrially, and/or transseptally. In some embodiments, the prosthetic valve may be configured for implantation in the annulus or orifice of a native heart valve structure (e.g., a native heart valve). For example, in FIGS. 10A-10H, prosthetic valve 6000 may be delivered to and expanded within native mitral valve 9030 such that prosthetic valve 6000 is anchored within native mitral valve 9030. In some embodiments, the exemplary prosthetic valve may be configured to grasp tissue of the native heart valve to more firmly anchor the prosthetic valve within the native heart valve. For example, an exemplary prosthetic valve may be configured to grasp the native leaflets and/or native heart valve annulus to firmly seat the prosthetic valve within the valve annulus, thus preventing the prosthetic valve from migrating or dislodging from within the native heart valve annulus.

In some embodiments, the prosthetic valve may include an annular valve body. The exemplary annular valve body may be configured to receive or otherwise support a flow control device, such as one or more leaflets, for regulating flow of blood or other bodily fluids through the prosthetic valve. For example, the flow control device (e.g., leaflets) may be secured directly to the valve body and/or to an additional structure that is in turn secured to the valve body. As a result, when the prosthetic valve is implanted within a native heart valve, the flow control device may regulate fluid passage through the native heart valve, thus restoring and/or replacing the functionality of the native valve. In some embodiments, the exemplary valve body may be annular or ring-shaped and may thus have at least one opening therein. In some embodiments, the at least one opening may extend longitudinally along the entire length of the annular valve body. For example, FIG. 2B illustrates an exemplary frame 2000 of a prosthetic heart valve. Heart valve frame 2000 may include an annular valve body 2020 having an axial lumen 2022 extending longitudinally therethrough. The annular valve body may be sized and configured to be seated within the orifice of a native heart valve. For example, as depicted in FIG. 10H, annular valve body 2020 may be situated within the orifice of mitral valve 9030, specifically between native leaflets 9032. In some embodiments, the annular valve body may be configured to have a smaller diameter, when fully-expanded, than the diameter of the orifice of the native head valve. In such embodiments, the annular valve body may be anchored in the native heart valve by anchoring structures, such as atrial anchoring arms and/or ventricular anchoring legs. Alternatively, the annular valve body may be configured to expand to an equal or greater diameter than the diameter of the heart valve orifice such that the annular valve body is anchored within the heart valve.

The annular valve body may have a circular, oval-shaped, elliptical, or D-shaped cross-section and may be symmetrical about at least one axis thereof. Alternatively, the annular valve body may have any suitable cross-sectional shape with at least one opening therein. In some embodiments, at least a portion of the annular valve body may be cylindrical, with a substantially constant diameter along the entire length thereof. Alternatively, the annular valve body may have a variable diameter at different portions thereof (e.g., at different longitudinal portions thereof). Advantageously, such a configuration may improve the seating of the annular valve body within the heart valve orifice, providing an improved pressure fit therebetween.

In some embodiments, the annular valve body may be expandable, such as between a radially-contracted configuration (e.g., a crimped state) and a radially-expanded configuration. For example, FIGS. 5A-5D illustrate an exemplary annular valve body 2020 in a radially-contracted configuration, while FIG. 5E illustrates annular valve body 2020 in a radially-expanded configuration. The diameter of the annular valve body may be reduced when the annular valve body assumes the radially-contracted configuration; for example, the annular valve body may be arranged in the radially-contracted configuration when the exemplary prosthetic valve is delivered to the implantation site. Conversely, the diameter of the annular valve body may be increased when the annular valve body assumes the radially-expanded configuration. For example, the annular valve body may expand to its largest possible diameter when it is in the radially-expanded configuration.

In some embodiments, the annular valve body may be configured for self-expansion to the radially-expanded configuration; that is, the annular valve body may be biased to assume the radially-expanded configuration due to, at least in part, the design and/or material composition of the annular valve body. The self-expanding valve body may be constructed of a shape memory material such as nickel titanium alloy (Nitinol), which may permit the annular valve body to expand to a pre-determined diameter upon removal of a constraining force and/or application of heat or energy. For example, the annular valve body may be contracted and held in the radially-contracted configuration by a constraining device, such as a sheath, catheter, stent, or delivery capsule. An example of such a constraining device is illustrated in FIG. 8C, which illustrates an exemplary prosthetic heart valve 6000 held in a radially-contracted configuration within a delivery capsule 7300. When the annular valve body is positioned at or near the implantation site (e.g., at the native mitral valve 9030), the constraining force (e.g., as applied by delivery capsule 7300) may be removed and the annular valve body allowed to self-expand to the radially-expanded configuration. Additionally, or alternatively, exemplary valve bodies may be configured to expand due to application of radially expansive forces thereupon. For example, the annular valve body may be placed, in its radially-contracted configuration, upon an expansion device such as a balloon catheter. Upon positioning at the implantation site, the expansion device may exert an outwardly-directed force upon the annular valve body, causing it to expand to the fully-expanded configuration.

In some embodiments, the exemplary valve body may be configured to radially expand independently of other components of the expandable prosthetic valve. As a result, the exemplary valve body may be configured to remain in a radially-contracted configuration while other components of the expandable prosthetic valve, such as one or more anchoring features, are deployed radially outward. For example, FIGS. 5B-5D depict valve body 2020 remaining in a radially-contracted configuration while atrial anchoring arms 2440 and ventricular anchoring legs 2240 are deployed radially outward (e.g., due to removal of a constraining delivery device from the arms and legs).

In some embodiments, the annular valve body may include an atrial inlet opening. The atrial inlet opening may be an opening or aperture at the atrial end of the axial lumen of the annular valve body; that is, the opening of the axial lumen which is configured to be situated at a location within the atrium that is furthest from an adjacent ventricle when the prosthetic valve is implanted within the native heart valve. For example, in FIG. 2A, annular valve body 2020 includes an atrial inlet opening 2032, which may be an opening at the atrial end of lumen 2022. In some embodiments, the atrial inlet opening may be configured as an opening or aperture through which blood or other fluid within the atrium may enter the axial lumen of the prosthetic valve. The blood or other fluid may flow along the axial lumen and exit into the ventricle. The prosthetic valve may include a flow control device, such as leaflets, within the axial lumen which may function as a one way valve. For example, the flow control device (e.g., leaflets) may permit blood flow in one direction (e.g., from the atrium to the ventricle) but may prevent blood flow in a second, opposite direction (e.g., from the ventricle to the atrium).

In some embodiments, the annular valve body may also include a ventricular outlet opening. The ventricular outlet opening may be an opening or aperture at the ventricular end of the axial lumen of the annular valve body; that is, the opening of the axial lumen which is configured to be situated at a location within the ventricle that is furthest from an adjacent atrium when the prosthetic valve is implanted within the native heart valve. For example, in FIG. 2A, annular valve body 2020 includes a ventricular outlet opening 2036, which may be an opening at the ventricular end of the axial lumen 2022. In some embodiments, the ventricular outlet opening may be configured as an opening or aperture through which blood or other fluid passing through the prosthetic valve (e.g., flowing along the axial lumen) may exit the prosthetic valve into the ventricle.

In some embodiments, the exemplary prosthetic valve may include a plurality of tissue anchors. The tissue anchors may be configured to anchor the prosthetic valve at an implantation site, such as within or near a native heart valve. In some embodiments, the tissue anchors may be configured to engage tissue of the native head valve, such as atrial tissue and/or ventricular tissue, to anchor the prosthetic valve within the native heart valve. In some embodiments, the tissue anchors may be configured to be positioned at least partially within a ventricle upon implantation of the prosthetic valve, and to engage ventricular tissue of a native mitral valve. For example, FIGS. 10E-10H depict ventricular anchoring legs 2240 of an exemplary prosthetic heart valve 6000. Ventricular anchoring legs 2240 are situated within ventricle 9020 and may engage the ventricular side of native mitral valve 9030 to secure prosthetic heart valve 6000 within the mitral valve; accordingly, ventricular anchoring legs 2240 may be considered tissue anchors in some embodiments. Additionally, or alternatively, the annular valve body may include tissue anchors configured to be positioned at least partially within an atrium upon implantation of the prosthetic valve, and to engage atrial tissue of a native mitral valve. For example, atrial anchoring arms 2440 depicted in FIGS. 10F-10H are situated within atrium 9010 and may engage the atrial side of native mitral valve 9030 to secure prosthetic heart valve 6000 within the mitral valve. Accordingly, atrial anchoring arms 2440 may additionally or alternatively be considered tissue anchors in some embodiments.

In some embodiments, the tissue anchors may be configured to minimize or prevent migration of the prosthetic valve into a surrounding heart chamber after the prosthetic valve is implanted. This may be due, at least in part, to the engagement of the tissue anchors with native tissue (e.g., the ventricular side of a native heart valve) and the inability of the tissue anchors to pass through the heart valve orifice after the prosthetic valve is implanted. For example, the tissue anchors may have sufficient length such that they may be configured to have a greater radius than the native heart valve. Additionally, or alternatively, the tissue anchors may be configured to grasp or clamp tissue of the native heart valve to further anchor the prosthetic valve in place. For example, in the embodiment of FIGS. 10G and 10H, ventricular anchoring legs 2240 may clamp tissue by exerting an atrially-directed force (that is, a force directed towards atrium 9010) on the tissue. Additionally, or alternatively, atrial anchoring arms 2440 may clamp the tissue by exerting a ventricularly-directed force (that is, a force directed towards ventricle 9020) on the tissue. These opposing forces may clamp or “sandwich” the native heart tissue between the arms and legs, thus firmly anchoring prosthetic heart valve 6000 within the native heart valve.

The prosthetic valve may include two tissue anchors, three tissue anchors, four tissue anchors, five tissue anchors, six tissue anchors, seven tissue anchors, eight tissue anchors, nine tissue anchors, ten tissue anchors, eleven tissue anchors, twelve tissue anchors, thirteen tissue anchors, fourteen tissue anchors, fifteen tissue anchors, sixteen tissue anchors, seventeen tissue anchors, eighteen tissue anchors, nineteen tissue anchors, twenty tissue anchors, or any other suitable number of tissue anchors. For example, exemplary prosthetic valve 6000 depicted in FIG. 2B may include twelve ventricular anchoring legs 2240 exemplary tissue anchors).

In some embodiments, the plurality of tissue anchors may be configured to extend from the annular valve body. For example, in FIG. 2A, ventricular anchoring legs 2240 (i.e., the exemplary tissue anchors) extend from leg attachment junctions 3802 of annular valve body 2020. In some embodiments, the tissue anchors may be physically connected to the annular valve body, such as by welding or adhesive. In some alternative embodiments, the tissue anchors may be integrally formed with the annular valve body. In some embodiments, at least one tissue anchor may extend from a single portion of the annular valve body. For example, in FIG. 2A, each ventricular anchoring leg 2240 may extend from a single leg attachment junction 3802, with no two legs extending from the same leg attachment junction. Alternatively, at least one tissue anchor may extend from multiple points of the annular valve body.

In some embodiments, the locations of connection between the tissue anchors and annular valve body may be spaced at a regular interval about a circumference of the annular valve body. For example, in FIG. 2A, the ventricular anchoring legs 2240 (i.e., the exemplary tissue anchors) may extend from the annular valve body 2020 at leg attachment junctions 3802. Leg attachment junctions 3802 may be spaced at a regular interval about the circumference of annular valve body 2020. Additionally, or alternatively, the locations of connection between the tissue anchors and annular valve body may be arranged along a plane perpendicular to the longitudinal axis of the prosthetic valve. For example, in FIG. 2A, the leg attachment, junctions 3802. may be arranged along a plane perpendicular to longitudinal axis 2800. That is, the leg attachment junctions 3802 may be situated at the same axial position along longitudinal axis 2800.

In some embodiments, the prosthetic valve may include an annular protective sleeve positioned about the of the ventricular outlet opening of the valve body. A sleeve may refer to a covering that fits over or encloses a part of the prosthetic valve. The protective sleeve may be positioned about the outlet opening rim; that is, the sleeve may cover the portion of the annular valve body surrounding and forming the ventricular outlet opening. For example, in FIGS. 6A-6C, protective sleeve 6102 is positioned about rim 6800 of ventricular outlet opening 2036 of the annular valve body 2020. Protective sleeve 6102 may extend around the entirety of the outlet opening rim 6800. For example, annular valve body 2020 may include one or more ventricular end delivery posts 2028. In some embodiments, protective sleeve 6102 may extend radially inside or radially outside from delivery posts 2028, such that protective sleeve 6102 may continue uninterrupted along the entire circumference of the outlet opening rim 6800.

In some embodiments, the protective sleeve may be annular or ring-shaped, so as to accommodate the circular shape of the ventricular outlet opening. In some embodiments, the protective sleeve may be cylindrical, with a substantially constant diameter along the entire axial length thereof. Alternatively, the protective sleeve may have a variable diameter at different portions thereof (e.g., at different longitudinal portions thereof). In some embodiments, the protective sleeve may be flexible, which may be due at least in part to the material construction of the protective sleeve.

In some embodiments, the protective sleeve may be at least partially constructed of a polymer. For example, the entirety of the protective sleeve may be constructed a polymer. In some embodiments, a polymer may refer to a large molecule, or macromolecule, composed of many repeating subunits. In some exemplary embodiments, the polymer may be synthetic. In some alternative embodiments, the polymer may be natural. In some embodiments, the protective sleeve may be constructed of multiple polymers.

In some embodiments, the protective sleeve may be constructed at least partially of polytetrafluoroethylene (PTFE), known also as “Teflon.” For example, the protective sleeve may be constructed entirely of PTFE. Advantageously, construction of the protective sleeve of PTFE may render the sleeve flexible. In some alternative embodiments, the protective sleeve may be constructed at least partially of a thermoplastic polymer, such as polyethylene terephthalate (PET), a polycarbonate, a polyoxymethylene, an acrylic, a nylon, a polyethylene, a polypropylene, a polystyrene, a polyvinyl chloride, or a fluoropolymer. Alternatively, in some embodiments, the protective sleeve may be constructed at least partially of bovine pericardium,

In some embodiments, the protective sleeve may be secured relative to the rim of the valve body outlet opening, at least in part, by stitching. In some embodiments, an additional securing mechanism, such as an adhesive, staples, rivets, or other suitable fasteners, may be used in combination with the stitching to secure the protective sleeve relative to the outlet opening rim. In some embodiments, the protective sleeve may be secured directly to the outlet opening rim; that is, the protective sleeve may contact the outlet opening rim and may be secured thereto by stitching. In some alternative embodiments, portions of the protective fabric coverings may be stitched to an intermediate structure, such as a protective liner, which may in turn be secured to the annular valve body. The stitching may be passed around the protective sleeve to secure the protective sleeve relative to the rim of the valve body outlet opening. For example, the stitching may wrap around the protective sleeve and the outlet opening rim, following a helical pattern along the circumference of the outlet opening rim. Alternatively, the stitching may pass around the protective sleeve in any other suitable pattern to secure it relative to the rim of the valve body outlet opening. For example, FIGS. 6A-6C illustrate helical stitching 6108 passing around protective sleeve 6102 to secure it to outlet opening rim 6800. In some embodiments, the stitching does not pass through the protective sleeve to secure it to the outlet opening rim; that is, the stitching wraps around the protective sleeve rather than passing through a portion of the protective sleeve. In some embodiments, the stitching may pass through the protective sleeve to secure it to the rim of the outlet opening.

In some embodiments, the stitching configured to secure the protective sleeve to the rim of the valve body outlet opening may pass between an area within the annular valve body and an area external to the annular valve body. For example, the stitching may pass between the inner lumen of the annular valve body and an area external to the radially outer surface of the annular valve body. For example, FIG. 6A illustrates the arrangement of stitching 6108 in a position radially outwards from the radially outer surface 4010 of annular valve body 2020, in addition, FIG. 6B illustrates the arrangement of stitching 6108 within the interior lumen 2022 of annular valve body 2020, in a position radially inward from the radially inner surface 4020 of the annular valve body. In some embodiments, stitching 6108 may extend through at least one opening in skirt layer 6100 to pass between the areas internal to and external to the annular valve body 2020. Additionally, or alternatively, stitching 6108 may extend through a gap formed between protective sleeve 6102 and skirt layer 6100. In some embodiments, due to the fact that the stitching wraps around the protective sleeve, which may in turn cover the outlet opening rim, portions of the stitching may be positioned in a ventricular direction from the ventricular end of the annular valve body. That is, portions of the stitching may be configured to extend further into the ventricle than the ventricular end of the annular valve body.

In some embodiments, the protective sleeve may be configured to wrap around the rim of the valve body outlet opening. That is, the protective sleeve may wrap around the outlet opening rim between the radially outer surface of the annular valve body and the radially inner surface of the annular valve body (i.e., the surface forming the inner lumen). For example, in FIG. 6B, protective sleeve 6102 wraps around outlet opening rim 6800 between the radially outer surface 4010 of annular valve body 2020 and the radially inner surface 4020 of annular valve body 2020. As a result, the protective sleeve may also cover the ventricular-most end of the annular valve body (that is, the very bottom of annular valve body 2020 in FIG. 6B).

In some embodiments, the protective sleeve may touch, or contact, one or both of a radially inner surface of the annular valve body and a radially outer surface of the annular valve body. In some embodiments, this may be due to the wrapping arrangement of the protective sleeve around the rim of the valve body outlet opening. For example, in FIG. 6B, protective sleeve 6102 contacts the inner surface 4020 and outer surface 4010 of annular valve body 2020.

In some embodiments, the protective sleeve may be configured to protect native tissue from being injured by the prosthetic valve, and in particular, by the ventricular outlet opening. For example, as illustrated in FIG. 10H, annular valve body 2020 may extend a short distance into ventricle 9020 after implantation of the prosthetic valve 6000, thus creating a risk of injury to ventricular anatomy such as the chordae tendineae 9022 illustrated in FIG. 9. For example, in some embodiments the prosthetic valve may be configured to protrude a distance of between 12 millimeters and 20 millimeters into the left ventricle. For example, and without limitation, in some embodiments the prosthetic valve may be configured to protrude a distance of between 16.3 and 16.5 millimeters into the left ventricle; for example, and without limitation, the prosthetic valve may be configured to protrude a distance of 16.4 millimeters into the left ventricle. In some alternative embodiments, the prosthetic valve may be configured to protrude a distance of between 14.6 and 14.8 millimeters into the left ventricle; for example, and without limitation, the prosthetic valve may be configured to protrude a distance of 14.7 millimeters into the left ventricle. Risk of injury may be due, in part, to the fact that annular valve body may be constructed of a rigid material (e.g., Nitinol) and may include pointed features along the outlet opening rim (e.g., ventricular end inner frame junctions 3004 illustrated in FIG. 2A). Due to the fact that the outlet opening rim (and any pointed features therein) is covered by the flexible protective sleeve, the chordae tendineae and other ventricular anatomy may be protected from injury caused by contact with the outlet opening rim.

In some embodiments, the prosthetic valve may include a skirt layer configured to extend about a circumference of the annular valve body, The skirt layer may cover the outer surface of at least a portion of the annular valve body; additionally, or alternatively, the skirt layer may cover the interior surface of at least a portion of the annular valve body. For example, prosthetic valve 6000 illustrated in FIGS. 6A-6C includes a skirt layer 6100 extending around a circumference (in particular, along the outer surface 4010) of the annular valve body 2020. The skirt layer may be blood-impermeable such that it may be configured to prevent blood leakage between the inner and outer surfaces of the annular valve body, instead directing blood through a flow control device, such as one or more leaflets, situated within the annular valve body. FIGS. 6D and 6E, for example, illustrate prosthetic leaflets 6602, 6604, 6606 situated within exemplary annular valve body 2020.

The skirt layer may be connected to the annular valve body, for example, by stitching, adhesive, staples, rivets, and/or any suitable fasteners, In some embodiments, the skirt layer may be at least partially constructed of a fabric that is impermeable to blood but which may be configured to allow for tissue ingrowth. For example, the skirt layer may be constructed of at least one synthetic material, such as polyester material or a biocompatible polymer. Examples of a polyester material may include polyethylene terephthalate (PET) and expanded polytetrafluoroethylene (ePTFE), either alone, or in combination with at least one additional material. In some alternative embodiments, the skirt layer may be at least partially constructed of a biological material, such as pericardial tissue (e.g., bovine, porcine, or equine pericardium) or other biological tissue.

In some embodiments, the skirt layer may contact and cover the radially outer surface of the valve body outlet opening. For example, FIG. 6B illustrates the arrangement of skirt layer 6100 around the radially outer surface of outlet opening rim 6800. In such embodiments, the protective cover may be situated over, and may thus cover, the portion of the skirt layer situated around the outlet opening rim. For example, FIG. 6B illustrates that around outlet opening rim 6108, protective covering 6102 may be situated over the skirt layer 6100, along the outer surface of the annular valve body. In some embodiments, the thickness of the protective sleeve may be larger than the thickness of the skirt layer. For example, in some embodiments the thickness of the protective sleeve may be at least twice as large as the thickness of the skirt layer. Advantageously, the thickness of the protective sleeve may contribute to the ability of the protective sleeve to prevent injury to native heart tissue, since the thickness may prevent features of the annular valve body from puncturing or projecting through the protective sleeve and injuring the native anatomy. In some alternative embodiments, the thickness of the protective sleeve may be smaller than the thickness of the skirt layer. In some further alternative embodiments, the thickness of the protective sleeve may be equal to the thickness of the skirt layer.

In some embodiments, the protective sleeve may be configured so as to not touch or contact at least one of the tissue anchors. For example, the protective sleeve may not touch or contact any of the tissue anchors. In some embodiments, the protective sleeve may not contact the tissue anchors when the tissue anchors are in the radially-contracted configuration. Additionally, or alternatively, the protective sleeve may not contact the tissue anchors when the tissue anchors are in the radially-expanded configuration. For example, FIG. 6A illustrates an embodiment in which ventricular anchoring legs 2240 (i.e., exemplary tissue anchors) are in a radially-expanded configuration. In the example of FIG. 6A, protective sleeve 6102 may be situated in a ventricular direction from the entire length of each ventricular anchoring leg 2240. As a result, protective sleeve 6102 does not contact any of the ventricular anchoring legs 2240. Similarly, in the example of FIG. 6A, protective sleeve 6102 may be situated in a ventricular direction from the entire length of each atrial anchoring arm 2440, such that the protective sleeve 6102 does not contact any of the atrial anchoring arms 2240.

In some embodiments, radial expansion and radial contraction of the annular valve body may be substantially unimpeded by the protective sleeve. That is, the protective sleeve may be configured so as not to obstruct or hinder movement of the annular valve body between the radially-contracted configuration and the radially-expanded configuration. For example, portions of the protective sleeve may be configured to fold together when the annular valve body is in the radially-contracted configuration, such that the diameter of the protective sleeve may be reduced to accommodate the reduced diameter of the annular valve body. Upon expansion of the annular valve body, the protective sleeve may unfold to assume an annular shape with a diameter substantially equal to the diameter of the outlet opening rim. Additionally, or alternatively, the protective sleeve may be sufficiently pliant so as to accommodate structural changes in the annular valve body during radial expansion and contraction thereof.

In some embodiments, movement of the tissue anchors between a radially-contracted configuration and a radially-expanded configuration may be substantially unimpeded by the protective sleeve. That is, the protective sleeve may be configured so as not to obstruct or hinder movement of the tissue anchors between their respective radially-contracted configuration and the radially-expanded configuration. This may be due, at least in part, to the fact that the protective sleeve does not touch or contact any portion of the tissue anchors, nor is the protective sleeve situated in an area through which the tissue anchors move when transitioning between the radially-contracted and radially-expanded configurations. For example, as illustrated in FIGS. 6A and 6B, the protective sleeve may be situated about the ventricular end 2025 of the annular valve body 2020. However, as FIGS. 5A-5E illustrate, neither the ventricular anchoring legs 2240 nor the atrial anchoring arms 2440 move through, or otherwise come in contact with, ventricular end 2025 when transitioning between the radially-contracted and radially-expanded configurations. As a result, the protective sleeve may be configured so as to not physically block or obstruct the movement of the tissue anchors.

In some embodiments, the exemplary prosthetic valve may include at least one delivery post secured to the valve body and configured to engage a delivery tool. The prosthetic valve may include one delivery post, two delivery posts, three delivery posts, four delivery posts, five delivery posts, or any other suitable number of delivery posts. The at least one delivery post may be physically connected to the annular valve body, for instance, by welding. Alternatively, the at least one delivery post and the annular valve body may be manufactured as a single unitary structure. The at least one delivery post may be constructed of the same material as the annular valve body and may extend in a ventricular direction from the ventricular end of the annular valve body. For example, the exemplary prosthetic valve illustrated in FIGS. 5A-5E may include three delivery posts 2028 extending in a ventricular direction from the ventricular end 2025 of the annular valve body 2020. The at least one delivery post may be configured to engage a delivery tool of the prosthetic valve, for example, to secure the prosthetic valve against movement relative to the delivery tool. For example, in FIG. 80, delivery posts 2028 are retained within recesses 8205 of an anchor disc 8200 of the exemplary delivery capsule 7300. Due to this engagement, prosthetic valve 6000 may be prevented from longitudinal movement relative to anchor disc 8200 until annular valve body 2020 radially expands, lifting delivery posts 2028 out of engagement with recesses 8205 and freeing prosthetic valve 6000 from engagement with anchor disc 8200.

In some embodiments, the at least one delivery post may be configured to extend in a ventricular direction beyond the exemplary protective sleeve. For example, the protective sleeve may be configured to extend around the outlet opening rim in such a manner that the protective sleeve passes around the at least one delivery post. In some embodiments, the protective sleeve may extend radially inside from the at least one delivery post, such that the at least one delivery post is situated at a radially outer position relative to the protective sleeve. In some alternative embodiments, the protective sleeve may extend radially outside of the at least one delivery post, such that the at least one delivery post is situated at a radially inward position relative to the protective sleeve. For example, FIG. 6B illustrates protective sleeve 6102 passing radially outside of the delivery posts 2028, such that the delivery posts 2028 are situated at a radially inward position relative to the protective sleeve 6102. In some embodiments, the at least one delivery post may extend from the annular valve body in a ventricular direction to a location beyond the protective sleeve. For example, FIG. 6B depicts delivery post 2028 extending in a ventricular direction (i.e., downward in FIG. 6B) beyond the ventricular end of the protective sleeve 6102 (i.e., the bottom surface of the sleeve 6102 in FIG. 6B). As a result, the at least one delivery post may be configured to engage a delivery tool without the at least one delivery post being covered or obstructed by the protective sleeve.

In some embodiments, the exemplary prosthetic valve may include a plurality of leaflets situated within the annular valve body. FIG. 6D, for example, illustrates prosthetic leaflets 6602, 6604, 6606 situated within the interior lumen 2022 of annular valve body 2020. The prosthetic valve may include two leaflets, three leaflets, four leaflets, or any other suitable number of leaflets. The leaflets may be constructed of various suitable materials, such as natural tissue (e.g., bovine pericardial tissue) or synthetic materials. The leaflets may be configured to function in a manner similar to the leaflets of the native mitral valve. For example, the leaflets may be configured to assume an open position (e.g., FIG. 6D), in which a space is formed between the leaflets, allowing blood and other fluids to pass between the leaflets, For example, when the leaflets are in the open position, they may be configured to permit blood passage from the atrium, through the prosthetic valve (in particular, through the lumen of the prosthetic valve), and into the ventricle. The leaflets may also be configured to assume a closed position (e.g., FIG. 6E), in which the leaflets may coapt with one another so as to prevent fluid passage between the leaflets. The leaflets may function as a one way valve, such that flow in one direction (e.g., from the atrium to the ventricle) opens the valve and flow in a second, opposite direction (e.g., from the ventricle to the atrium) closes the valve. In some embodiments, the leaflets may be configured to open during diastole and close during systole.

In some embodiments, the leaflets may be connected to certain portions of the annular valve body. For example, the atrial ends of the leaflets may be connected to the annular valve body or to an intermediate structure (e.g., a liner) which may, in turn, be connected to the annular valve body. The leaflets may be connected to the annular valve body and/or to the intermediate structure by stitching, adhesive, staples, rivets, and/or any suitable fasteners. For example, in FIGS. 6D and 6E, leaflets 6602, 6604, and 6606 are connected, along their respective atrial ends, to inner liner 6400, which may be situated at least in part within the central lumen of annular valve body 2020. Leaflets 6602, 6604, and 6606 may be connected to inner liner 6400 via stitching 6608 and/or by any suitable fastening means. Inner liner 6400 may, in turn, be connected to the annular valve body 2020, thus securing the leaflets to the annular valve body. Additionally, or alternatively, the ventricular ends of the leaflets may be connected to the annular valve body or to an intermediate structure (e.g., a liner) which may, in turn, be connected to the annular valve body. For example, as illustrated in FIG. 6C, leaflets 6602, 6604 (as well as leaflet 6606, which is not depicted in FIG. 60) may be connected to one or more ventricular end delivery posts 2028, such as by stitching 6610 that may loop around the one or more delivery posts 2028 to secure the leaflets to delivery post 2028.

In some embodiments, a point of connection between the leaflets and the annular valve body (e.g., the stitching 6610 securing leaflets 6602, 6604, 6606 to delivery post 2028) may be aligned in a common lateral plane with the protective sleeve 6102. That is, the protective sleeve and the point of connection between the leaflets and the at least one delivery post may be arranged at the same axial position relative to a longitudinal axis of the prosthetic valve. As a result, the protective sleeve and the point of connection may be configured at a common axial position along the longitudinal axis of the prosthetic valve. For example, in embodiments in which the at least one delivery post is situated at a radially inward position relative to the protective sleeve, the point of connection between the leaflets and the delivery post may also be situated at a radially inward position relative to the protective sleeve. In some alternative embodiments, a point of connection between the leaflets and the annular valve body (e.g., the stitching 6610 securing leaflets 6602, 6604, 6606 to delivery post 2028) may be situated in an atrial direction relative to the protective sleeve 6102. In further alternative embodiments, a point of connection between the leaflets and the annular valve body (e.g., the stitching 6610 securing leaflets 6602, 6604, 6606 to delivery post 2028) may be situated in a ventricular direction relative to the protective sleeve 6102.

In some embodiments, the exemplary tissue anchors of the prosthetic valve may be configured to engage ventricular tissue of a native heart valve, so as to anchor the prosthetic valve within the native heart valve. For example, the tissue anchors may be configured to contact the ventricular surface of the native heart valve, so as to prevent migration of the prosthetic valve in an atrial direction. Additionally, or alternatively, the tissue anchors may be configured to grasp or clamp tissue of the native heart valve to further anchor the prosthetic valve in place. For example, FIGS. 10E-10H depict ventricular anchoring legs 2240 (i.e., exemplary tissue anchors) situated within ventricle 9020. Ventricular anchoring legs 2240 may engage the ventricular side of native mitral valve 9030 to secure prosthetic heart valve 6000 within the mitral valve.

In some embodiments, the exemplary prosthetic valve may additionally include a plurality of atrial tissue anchors. In some embodiments, the atrial tissue anchors may be configured to engage atrial tissue of the native head valve to anchor the prosthetic valve therein. In some embodiments, the atrial tissue anchors may be configured to be positioned at east partially within an atrium upon implantation of the prosthetic valve, and to engage atrial tissue of the native heart valve (e.g., a native mitral valve). For example, FIGS. 10F-10H depict atrial anchoring arms 2440 of an exemplary prosthetic head valve 6000. Atrial anchoring arms 2440 are situated within atrium 9010 and may engage the atrial side of native mitral valve 9030 to secure prosthetic heart valve 6000 within the mitral valve; accordingly, atrial anchoring arms 2440 may be considered atrial tissue anchors in some embodiments.

In some embodiments, the atrial tissue anchors may be configured to minimize or prevent migration of the prosthetic valve, including in a ventricular direction (that is, towards the ventricle), after the prosthetic valve is implanted. This may be due, at least in part, to the engagement of the atrial tissue anchors with native heart tissue (e.g., the atrial side of the native mitral valve) and the inability of the atrial tissue anchors to pass through the heart valve orifice after the prosthetic valve is implanted. For example, the atrial tissue anchors may have sufficient length such that they may be configured to have a greater radius than the native heart valve. Additionally, or alternatively, the atrial tissue anchors may be configured to grasp or clamp tissue of the native heart valve to further anchor the prosthetic valve in place. For example, in the embodiment of FIGS. 10G and 10H, atrial anchoring arms 2440 (i.e., the exemplary atrial tissue anchors) may clamp tissue by exerting a ventricularly-directed force (that is, a force directed towards ventricle 9020) on the tissue, thus creating a sandwiching effect in coordination with ventricular anchoring legs 2240 which may firmly anchor prosthetic heart valve 6000 within the mitral valve.

The prosthetic valve may include two atrial tissue anchors, three atrial tissue anchors, four atrial tissue anchors, five atrial tissue anchors, six atrial tissue anchors, seven atrial tissue anchors, eight atrial tissue anchors, nine atrial tissue anchors, ten atrial tissue anchors, eleven atrial tissue anchors, twelve atrial tissue anchors, thirteen atrial tissue anchors, fourteen atrial tissue anchors, fifteen atrial tissue anchors, sixteen atrial tissue anchors, seventeen atrial tissue anchors, eighteen atrial tissue anchors, nineteen atrial tissue anchors, twenty atrial tissue anchors, or any other suitable number of atrial tissue anchors. For example, exemplary prosthetic valve 6000 depicted in FIG. 2B may include twelve atrial anchoring arms 2440 (i.e., exemplary atrial tissue anchors).

In some embodiments, the annular valve body may include one or more frames. In some embodiments, the annular valve body may include an outer frame and an inner frame situated at least partially within the outer frame. In some embodiments, one or both of the inner frame and the outer frame may be annular, and the inner frame may be positioned within an opening of the outer frame. For example, FIG. 2A depicts an exemplary prosthetic valve frame 2000 having an outer frame 2200 and an inner frame 2400. In some alternative embodiments, the inner frame may be situated entirely within the outer frame. One or both of the inner frame and the outer frame may be configured to radially expand between a radially-contracted configuration (e.g., a crimped state) and a radially-expanded configuration. In some embodiments, the inner frame may be configured to receive or otherwise support a flow control device, such as one or more leaflets, for regulating flow of blood or other bodily fluids through the prosthetic valve.

In some embodiments, the tissue anchors configured to engage ventricular tissue may be configured to extend from the annular outer frame. Additionally, or alternatively, the exemplary atrial tissue anchors may be configured to extend from the inner frame. For example, FIG. 3A depicts atrial anchoring arms 2440 (i.e., the exemplary atrial tissue anchors) extending from inner frame 2400, and FIG. 3C depicts ventricular anchoring legs 2240 the exemplary ventricular tissue anchors) extending from outer frame 2200. In some embodiments, the atrial tissue anchors and the ventricular tissue anchors may be physically connected to the inner frame and annular outer frame, respectively, such as by welding or adhesive. In some alternative embodiments, the atrial tissue anchors and the ventricular tissue anchors may be integrally formed with the inner frame and annular outer frame, respectively.

In some embodiments, the locations of connection between the atrial tissue anchors and the inner frame may be spaced at a regular interval about a circumference of the inner frame. For example, in FIG. 2A, the atrial anchoring arms 2440 (i.e., the exemplary atrial tissue anchors) may extend from inner frame 2400 at arm attachment junctions 3202. Arm attachment junctions 3202 may be spaced at a regular interval about the circumference of inner frame 2400. Additionally, or alternatively, the locations of connection between the atrial tissue anchors and the inner frame may be arranged along a plane perpendicular to the longitudinal axis of the prosthetic valve. For example, in FIG. 2A, the arm attachment junctions 3202 may be arranged along a plane perpendicular to longitudinal axis 2800. That is, the arm attachment junctions 3202 may be situated at the same axial position along longitudinal axis 2800.

In some embodiments, the protective sleeve may be configured to contact a radially inner surface of the inner frame and a radially outer surface of the annular outer frame. For example, the ventricular end of the inner frame may be situated within the ventricular end of the annular outer frame, such that both the inner frame and outer frame form the outlet opening rim. The protective sleeve may wrap around the outlet opening rim, thus extending from the radially inner surface of the inner frame to the radially outer surface of the annular outer frame. For example, FIG. 6A illustrates protective sleeve 6102 extending around and contacting exemplary outer frame 2200, and FIG. 6B illustrates protective sleeve 6102 extending around and contacting exemplary inner frame 2400.

The foregoing description has been presented for purposes of illustration. It is not exhaustive and is not limited to precise forms or embodiments disclosed. Modifications and adaptations of the embodiments will be apparent from consideration of the specification and practice of the disclosed embodiments. For example, while certain components have been described as being coupled to one another, such components may be integrated with one another or distributed in any suitable fashion.

Moreover, while illustrative embodiments have been described herein, the scope includes any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of aspects across various embodiments), adaptations and/or alterations based on the present disclosure. The elements in the claims are to be interpreted broadly based on the language employed in the claims and not limited to examples described in the present specification or during the prosecution of the application, which examples are to be construed as nonexclusive. Further, the steps of the disclosed methods can be modified in any manner, including reordering steps and/or inserting or deleting steps.

The features and advantages of the disclosure are apparent from the detailed specification, and thus, it is intended that the appended claims cover all systems and methods falling within the true spirit and scope of the disclosure. As used herein, the indefinite articles “a” and “an” mean “one or more.” Similarly, the use of a plural term does not necessarily denote a plurality unless it is unambiguous in the given context. Words such as “and” or “or” mean “and/or” unless specifically directed otherwise. Further, since numerous modifications and variations will readily occur from studying the present disclosure, it is not desired to limit the disclosure to the exact construction and operation illustrated and described, and, accordingly, all suitable modifications and equivalents may be resorted to, failing within the scope of the disclosure.

Other embodiments will be apparent from consideration of the specification and practice of the embodiments disclosed herein. It is intended that the specification and examples be considered as example only, with a true scope and spirit of the disclosed embodiments being indicated by the following claims. 

1. An expandable prosthetic valve for implantation within a native heart valve, the prosthetic valve comprising: an expandable annular valve body having: an atrial inlet opening, a ventricular outlet opening, and a plurality of tissue anchors extending from the annular valve body; and a flexible annular protective sleeve positioned about the rim of the valve body outlet opening and affixed to the valve body outlet opening; wherein the protective sleeve is situated over a skirt layer extending about a circumference of the valve body and a thickness of the protective sleeve is larger than a thickness of the skirt layer.
 2. The prosthetic valve of claim 1, wherein the protective sleeve is constructed of a polymer.
 3. The prosthetic valve of claim 1, wherein the protective sleeve is constructed of PTFE.
 4. The prosthetic valve of claim 1, wherein stitching is passed around the protective sleeve to secure it relative to the rim of the valve body outlet opening.
 5. The prosthetic valve of claim 4, wherein the stitching does not pass through the protective sleeve.
 6. The prosthetic valve of claim 4, wherein the stitching passes between an area within the annular valve body and an area external to the annular valve body.
 7. The prosthetic valve of claim 1, wherein the protective sleeve wraps around the rim of the valve body outlet opening.
 8. The prosthetic valve of claim 1, wherein the protective sleeve contacts a radially inner surface of the annular valve body and a radially outer surface of the annular valve body.
 9. The prosthetic valve of claim 1, wherein the protective sleeve is configured to protect chordae tendineae from damage by the prosthetic valve. 10-11. (canceled)
 12. The prosthetic valve of claim 1, wherein the protective sleeve does not contact the plurality of tissue anchors.
 13. The prosthetic valve of claim 1, wherein radial expansion and contraction of the annular valve body is substantially unimpeded by the protective sleeve.
 14. The prosthetic valve of claim 1, wherein movement of the plurality of tissue anchors between a radially-contracted configuration and a radially-expanded configuration is substantially unimpeded by the protective sleeve.
 15. The prosthetic valve of claim 1, further comprising: at least one post secured to the annular valve body and configured to engage a delivery tool, wherein the at least one post extends in a ventricular direction beyond the protective sleeve.
 16. The prosthetic valve of claim 15, wherein the at least one post is situated at a radially inward position relative to the protective sleeve.
 17. The prosthetic valve of claim 1, further comprising: a plurality of leaflets situated within the annular valve body, wherein a point of connection between the leaflets and the annular valve body is: aligned in a common lateral plane with the protective sleeve, or situated in an atrial direction relative to the protective sleeve.
 18. The prosthetic valve of claim 1, wherein the tissue anchors are configured to engage ventricular tissue of a native heart valve, and wherein the prosthetic valve further comprises a plurality of atrial tissue anchors configured to engage atrial tissue of the native heart valve.
 19. The prosthetic valve of claim 18, wherein the annular valve body includes an annular outer frame and an inner frame situated at least partially within the annular outer frame, wherein the tissue anchors configured to engage ventricular tissue extend from the annular outer frame, and wherein the atrial tissue anchors extend from the inner frame.
 20. The prosthetic valve of claim 19, wherein the protective sleeve contacts a radially inner surface of the inner frame and a radially outer surface of the annular outer frame. 